(84 days)
OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
The provided text does not contain information about specific acceptance criteria or a study that evaluates a device against such criteria. The document is a 510(k) clearance letter from the FDA for a device called "OptiView/Medical Image Record and Display System."
The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market entry based on comparison with existing similar devices, rather than through a detailed performance study with explicit acceptance criteria as would be expected for a novel AI device.
Therefore, I cannot extract the requested information such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information. This type of information is typically found in a clinical study report or a more detailed submission document, not within the FDA clearance letter itself.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).